Milrinone Inhaled in Cardiac Surgery

This study has been completed.
Sponsor:
Collaborators:
Heart and stoke fondation of Quebec
Organon
Canadian Anesthesiologists' Society
Information provided by (Responsible Party):
Andre Denault, Montreal Heart Institute
ClinicalTrials.gov Identifier:
NCT00819377
First received: January 8, 2009
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

Pulmonary hypertension is an important morbidity factor in patients having to undergo cardiac surgery with cardiopulmonary bypass (ECC). Milrinone used in inhalation, shows evidence of being a pulmonary vasodilator able to possibly contribute to the reduction of pressure on the pulmonary artery.


Condition Intervention Phase
Valvular Stenosis
Valvular Insufficiency
Hypertension, Pulmonary
Coronary Artery Disease
Drug: Milrinone
Drug: Normal saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 2- Inhaled Milrinone Prevents the Increase in Pulmonary Artery Pressure After CPB

Resource links provided by NLM:


Further study details as provided by Montreal Heart Institute:

Primary Outcome Measures:
  • To demonstrate that inhaled milrinone administered before CPB is superior to placebo in reducing the severity of difficult separation from bypass [ Time Frame: End of CPB ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reduction in morbidity and mortality post-op [ Time Frame: At discharge, 3 months, 6 months and 1 year by telephone ] [ Designated as safety issue: Yes ]
  • Reduction in pulmonary artery pressure [ Time Frame: Same day before and after CPB ] [ Designated as safety issue: Yes ]
  • Right ventricular function measured using transthoracic echocardiography (TTE) and TEE [ Time Frame: Same day before and after the CPB ] [ Designated as safety issue: Yes ]
  • Serum levels of milrinone in relation with the pharmacodynamic marker [ Time Frame: Same day pre CPB per CPB and post CPB ] [ Designated as safety issue: Yes ]
  • reduction of the composite index of hemodynamic complications (defined as hospital death, vasoactive drugs > 24 hours and post-op cardiac arrest), [ Time Frame: 24 hrs post op and hospital discharge ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 124
Study Start Date: February 2009
Study Completion Date: December 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Normal saline
Normal saline by inhalation over 15 min
Drug: Normal saline
5 ml normal saline by inhalation over 15 min
Other Names:
  • Placebo
  • Normal saline
  • Comparator
Active Comparator: Milrinone
Inhaled milrinone 5 mg(as for the injectable solution)
Drug: Milrinone
inhaled milrinone 5 mg (as for the injectable solution)
Other Names:
  • Milrinone Cardiac Surgery
  • Milrinone inhaled
  • Inhaled milrinone reduces pulmonary artery pressure

Detailed Description:

This controlled, randomized, double-blind study will aim at confirming the efficiency as well as the security of Milrinone, used in inhalation, to diminish the degree of pulmonary hypertension before the cardiopulmonary bypass (ECC) circulation. In addition, the pharmacokinetic and echo graphic repercussions of administering the medication will be analysed. At the present time, there is no data on the pharmacokinetics of the medication when it's administered through inhalation. For this reason, we would like to study the serous rate of the medication in the minutes following its administration through inhalation.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients scheduled for elective valvular or complex (2 or more valves or
  • valve and revascularization) cardiac surgery under CPB with preoperative PHT defined as mean pulmonary artery pressure (MPAP) over 30 mmHg or
  • systolic pulmonary artery pressure (SPAP) over 40 mmHg (using preoperative right-sided catheterization or estimated by echocardiography).

Exclusion Criteria:

  • Cardiac surgery not requiring CPB, contraindication to TEE (esophageal pathology or unstable cervical spine) and emergency surgery.
  • Patients will be recruited the day before surgery and randomized using computerized cards by the pharmacy department
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819377

Locations
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Andre Denault
Heart and stoke fondation of Quebec
Organon
Canadian Anesthesiologists' Society
Investigators
Principal Investigator: Denault André, MD FRCPC Montreal Heart Institute
  More Information

Publications:

Responsible Party: Andre Denault, MD FRCPC ABIM-CCM, Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT00819377     History of Changes
Other Study ID Numbers: 08-1004
Study First Received: January 8, 2009
Last Updated: October 23, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Montreal Heart Institute:
Valvular surgery
pulmonary artery pressure

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hypertension
Hypertension, Pulmonary
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Milrinone
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014